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May 23, 2026DrugsOpen Access

SPH3127 proves non-inferior to valsartan for lowering diastolic blood pressure in mild-to-moderate hypertension.

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Why the study?

The study was conducted to evaluate the efficacy and safety of sitokiren (SPH3127) tablet compared to valsartan capsule in patients with mild-to-moderate essential hypertension.

Does sitokiren (SPH3127) 100 mg once daily reduce mean sitting diastolic blood pressure non-inferiorly to valsartan 80 mg once daily in adult patients with mild-to-moderate essential hypertension?

Population

Patients with mild-to-moderate essential hypertension (129 randomised in stage 1, 828 in stage 2)

Comparison

SPH3127 tablet vs valsartan capsule 80 mg QD

Design

Multicentre, randomised, double-blind, parallel, 2-stage Phase III trial

Follow-up

12 consecutive weeks

Key result

SPH3127 100 mg once daily was non-inferior to valsartan 80 mg in reducing mean sitting diastolic blood pressure at 12 weeks (difference -0.35 mmHg, p=0.005) in patients with mild-to-moderate essential hypertension.

Authors

QLQiang LvCMChangsheng MaFWFang Wang

Discussion

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Overview

Provides a novel direct renin inhibitor option for mild-to-moderate hypertension; extends the evidence base for renin-angiotensin system blockade.

Key Points

  • To evaluate the efficacy and safety of SPH3127 tablet compared to valsartan in patients with mild-to-moderate essential hypertension.
  • Multicentre, randomized, double-blind Phase III trial with two stages.
  • First stage involved randomization to three dosages of SPH3127 or valsartan for 12 weeks.
  • Second stage randomized patients to continue SPH3127 or valsartan based on first stage results.
  • The 100 mg SPH3127 group had an msDBP reduction of -8.17 mmHg (p = 0.005) from baseline.
  • At Week 12, SPH3127 and valsartan groups had changes of 5.97 mmHg and 6.32 mmHg respectively, with an inter-group difference of -0.35 mmHg.
  • 61.1% of SPH3127 group had treatment emergent adverse events, compared to 56.2% in the valsartan group.

Study Design

Type

RCT (n=828)

Blinding

Double-blind

Randomization

Block randomization (1:1)

Multicenter

Yes

Structured PICO

Does sitokiren (SPH3127) 100 mg once daily reduce mean sitting diastolic blood pressure non-inferiorly to valsartan 80 mg once daily in adult patients with mild-to-moderate essential hypertension?

P
Population
828 Chinese adults (aged ≥ 18 years) with mild-to-moderate essential hypertension. Mean age ~53.5 years, ~60% male. Key exclusions: secondary hypertension, suspected grade 3 hypertension, acute hypertension, severe cardiovascular disease within 6 months, severe or malignant retinopathy, poorly controlled diabetes.
I
Intervention
Sitokiren (SPH3127) tablet 100 mg oral once daily for 12 consecutive weeks.
C
Comparator
Valsartan capsule 80 mg oral once daily for 12 consecutive weeks (double-dummy design).
O
Outcome
Change from baseline in mean sitting diastolic blood pressure (msDBP) at Week 12.surrogate

Main Result

Effect estimate: Difference -0.35 mmHg (95% CI -1.48, 0.78)

Absolute Event Rate: 5.97% vs 6.32%

p-value: p=0.005

Sitokiren (SPH3127) 100 mg once daily is a safe and effective novel direct renin inhibitor that provides non-inferior diastolic blood pressure reduction compared to valsartan 80 mg in patients with mild-to-moderate essential hypertension.

Limitations

  • Conducted only in Chinese patients, so results might not be generalizable to other geographic regions and ethnicities
  • The observation period was short
  • Focused only on the 100-mg QD dose and did not explore doses beyond this range
  • Conducted only in Chinese patients, limiting generalisability to other geographic regions and ethnicities.
  • Short observation period (12 weeks).
  • Focused only on the 100-mg QD dose and did not explore doses beyond this range, which may reflect a potential ceiling effect.

Cite This Study

Lv et al. (2026) conducted an RCT in Mild-to-moderate essential hypertension (n=828). SPH3127 (sitokiren) vs. Valsartan 80 mg once daily was evaluated on Change from baseline in mean sitting diastolic blood pressure (msDBP) at Week 12 (Difference -0.35 mmHg, 95% CI -1.48, 0.78, p=0.005). SPH3127 100 mg once daily was non-inferior to valsartan 80 mg in reducing mean sitting diastolic blood pressure at 12 weeks (difference -0.35 mmHg, p=0.005) in patients with mild-to-moderate essential hypertension.

synapsesocial.com/papers/6a1146bb48a409a3a49e0025https://doi.org/10.1007/s40265-026-02315-z
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A randomized, double-blind, placebo-controlled, phase IIa, clinical study on investigating the efficacy and safety of SPH3127 tablet in patients with essential hypertension2024 · 4 citations
  2. 2Pharmacokinetics, mass balance, and metabolism of [14C]SPH3127 (sitokiren), a novel direct renin inhibitor in humans2026
  3. 3Aliskiren, an Orally Effective Renin Inhibitor, Provides Antihypertensive Efficacy Alone and in Combination With Valsartan2006 · 214 citations
  4. 4Clinical observation of sacubitril valsartan sodium in the treatment of resistant hypertension: A randomized clinical trial2022 · 7 citations
  5. 5Long-term safety, tolerability and efficacy of aliskiren in combination with valsartan in patients with hypertension: a 6-month interim analysis2008 · 43 citations